U.S. patent application number 10/698835 was filed with the patent office on 2005-05-05 for quick-release torquer apparatus for delivering and maintaining a medical guidewire.
Invention is credited to Arnott, Richard J..
Application Number | 20050096566 10/698835 |
Document ID | / |
Family ID | 34550771 |
Filed Date | 2005-05-05 |
United States Patent
Application |
20050096566 |
Kind Code |
A1 |
Arnott, Richard J. |
May 5, 2005 |
Quick-release torquer apparatus for delivering and maintaining a
medical guidewire
Abstract
The present invention provides a torquer for maneuvering a
medical guidewire during endovascular surgical procedures or the
like, which can be easily positioned and re-positioned along the
length of the wire. A clamp-like device is formed with a top arm
and a bottom arm connected to one another by means of a flap hinge.
A horizontal slit is defined within the flap hinge, and a vertical
slit is defined on a clamping tongue positioned at the top distal
end of the top arm, such that the torquer is placed onto the
guidewire and snapped into place with the guidewire penetrating the
vertical slit. A wire channel means is further defined between the
two arms to hold the guidewire within the torquer.
Inventors: |
Arnott, Richard J.;
(Pittsburgh, PA) |
Correspondence
Address: |
MCKAY & ASSOCIATES, PC.
801 MCNEILLY ROAD
PITTSBURG
PA
15226
US
|
Family ID: |
34550771 |
Appl. No.: |
10/698835 |
Filed: |
October 31, 2003 |
Current U.S.
Class: |
600/585 ;
604/528 |
Current CPC
Class: |
A61M 2025/09116
20130101; A61M 25/09041 20130101 |
Class at
Publication: |
600/585 ;
604/528 |
International
Class: |
A61M 025/09 |
Claims
I claim:
1. A torquer for maneuvering a guidewire, comprising: a top arm
having a top distal end and a top proximal end; a clamping tongue
disposed downwardly from said top distal end; a bottom arm having a
bottom distal end and a bottom proximal end, said bottom proximal
end flexibly connected to said top proximal end by means of a flap
hinge; a proximal slit defined horizontally within said flap hinge;
and, a distal slit defined vertically within said clamping tongue,
wherein said proximal slit and said distal slit are adapted to
receive said guidewire.
2. The torquer of claim 1, further comprising a wire channel means
for positioning said guidewire between said bottom arm and said top
arm when said top arm and said bottom arm are clamped together.
3. The torquer of claim 1, further comprising a torque-assist area
defined on both said top arm and said bottom arm.
4. The torquer of claim 1, further comprising a grip surface
defined on said top arm near said top distal end.
5. The torquer of claim 1, further comprising a grip surface
defined on said bottom arm near said bottom distal end.
6. The torquer of claim 1, further comprising a means for
releasably clamping said clamping tongue to said bottom distal
end.
7. A torquer for maneuvering a guidewire, comprising: a top arm
having an underlying surface; a bottom arm hingedly connected to
said top arm by means of a flap hinge, said bottom arm having a top
surface opposed and aligned with said underlying surface of said
top arm; and, a wire channel means for positioning said guidewire
between said bottom arm and said top arm, said wire channel means
integrally formed on at least one of said top surface or said
underlying surface.
8. The torquer of claim 7, further comprising a proximal slit
defined horizontally within said flap hinge.
9. The torquer of claim 7, further comprising a torque-assist area
defined on both said top arm and said bottom arm.
10. The torquer of claim 7, further comprising a grip surface
defined on said top arm.
11. The torquer of claim 7, further comprising a grip surface
defined on said bottom arm.
12. The torquer of claim 7, further comprising a means for
releasably clamping said top arm to said bottom arm.
13. A torquer for maneuvering a guidewire, comprising: a top arm
having a top distal end and a top proximal end; a bottom arm
hingedly connected to said top arm and having a bottom distal end
and a bottom proximal end; a bottom lip abutting said bottom distal
end; a clamping tongue disposed downwardly from said top distal
end; a distal slit defined vertically within said clamping tongue
adapted to receive said guidewire; and a tongue clip formed
integral to said clamping tongue projecting upwardly and inwardly
from a tip of said clamping tongue configured to snap onto said
bottom lip of said bottom distal end wherein said top arm may be
releasably clamped to said bottom arm with said guidewire retained
within said distal slit.
14. The torquer of claim 13, further comprising a torque-assist
area defined on both said top arm and said bottom arm.
15. The torquer of claim 13, further comprising a grip surface
defined on said top arm.
16. The torquer of claim 13, further comprising a proximal slit
defined horizontally within said flap hinge.
17. The torquer of claim 13, further comprising a wire channel
means for positioning said guidewire between said bottom arm and
said top arm when said top arm and said bottom arm are clamped
together, said wire channel means integrally formed on an
underlying surface of said top arm and a top surface of said bottom
arm.
Description
BACKGROUND
[0001] 1. Field of the Invention
[0002] The present invention is directed to a method and apparatus
for delivering, manipulating and repositioning a guidewire to and
beyond an operative site in any of a variety of medical procedures
employed to treat any number of medical conditions in human and/or
animal patients.
[0003] 2. Description of the Related Art
[0004] In many medical procedures, endovascular devices are
delivered during diagnostic and surgical procedures, and it is
useful and/or necessary to deliver these devices on or over a
medical guidewire.
[0005] Minimally invasive interventional medical diagnosis
procedures in general, and minimally invasive endovascular therapy
in particular, are medical events where devices are delivered over
a guidewire during the procedure, and each has enjoyed
unprecedented expansion to treat patients because of the numerous
medical benefits associated with not having to enter the body
through more invasive surgical techniques. These benefits include,
but are not limited to, less trauma and/or scarring for patients,
less time to heal, less risk of infection and decreased length of
hospital stays, to name but a few.
[0006] More particularly, minimally invasive endovascular therapy
is often used to treat diseased vessels, e.g., arteries and veins.
With such therapy, small instruments are inserted into the vessels
through a puncture or access opening made in one of the vessels at
an entry site and are advanced through the circulatory system to an
operative site where the vessel has become diseased. There, the
instruments are used to diagnose and/or repair the diseased or
operative site. Typically, the goal of such therapy is to identify
and and treat by dilation full or partial blockages of the diseased
vessel. Such blockages may have developed over time or may have
developed quickly, as for example, in response to an injury. One
common source of such blockage is thromboemboli which has formed in
the vessel. Thrombus is an aggregation of platelets, fibrin,
clotting factors and cellular components of blood that
spontaneously form and attach on the interior wall of a vein or
artery. Thromboemboli are emboli of thrombus which operate to
partially or completely occlude the interior or lumen of the blood
or other vessel.
[0007] Techniques to open and/or maintain the dilation of the
partially or completely occluded lumen of blood or other vessels
include balloon angioplasty and stenting. Balloon angioplasty is
the delivering of a balloon over a guidewire and positioning it in
an obstruction or partially occluded section of the vessel,
inflating the balloon to compress the build up. Stenting is the
temporary or permanent inserting, again over a guidewire, of a
tube-like support within the vessels to keep the vessel open.
[0008] Minimally invasive endovascular diagnosis and therapy has
the significant advantages of being less invasive than traditional
surgical techniques and causing less trauma to the patient.
However, these procedures are also inherently more complicated:
they may inadvertently puncture the vessel wall or dislodge and
free particles or objects during the procedures as discussed above.
Particularly, this complication results from the small clearances
between instruments and the interior of the vessels of the body,
and reaching the operative site with the tools is very difficult
(due to the considerable branching of the circulatory system that
may occur between the entry site into the blood vessel and the
operative site). Endovascular diagnosis and therapy is further
complicated by the fact that the entry site is often far from the
operative site, as for example, where the entry site is in the
thigh at the femoral artery and the operative site is located in
the neck at the carotid artery. Even when the surgeon's instruments
have been properly advanced to the operative site, manipulating the
tools to perform their respective functions at the operative site
is often difficult for the surgeon due to many factors including
guidewire movement, the close quarters at the operative site and
the distance between the entry site and the operative site.
[0009] One method and apparatus commonly used by surgeons to ensure
the tools reach the operative site is to first thread a simple
guidewire to or beyond the operative site. Thereafter, various
tools are threaded over the guidewire by the surgeon to reach the
operative site. It is an important aspect of such guidewires that
they must be easy to manipulate within the vessels, including, in
certain cases, through lesions or areas of blockage in the vessel
by the surgeon. In addition to exhibiting sufficient resiliency so
as to be pushable in the vessel, the guidewire must exhibit
sufficient flexibility and maneuverability to enable the surgeon to
traverse the many twists and turns of the circulatory (or other)
system to reach the operative site.
[0010] Two major aspects which influence the ability of a surgeon
to manipulate the guidewire through the circulatory or other system
are the guidewire's advancement and "torquability". As defined
herein, "torquability" is a qualitative measure of the surgeon's
ability to rotate the proximal region of the guidewire that extends
outside of the patient's body during the advancement of the
guidewire to the operative site and translate that rotation to the
distal end of the guidewire. It is this rotation at the proximal
region of the guidewire, when mechanically transmitted to the
distal end of the guidewire, which advances the distal end through
the patient's blood or other vessels to the operative site. A lack
of correlation between rotation at the proximal region of the
guidewire and rotation at the distal end of the guidewire is
referred to as reduced torquability and is undesirable. A high
degree of correlation is referred to as a high degree of
torquability and is desirable. As may be appreciated, it is most
desirable for the guidewire to have an exact correlation or high
torquability between the rotation applied proximally at the
proximal region of the guidewire and the rotation developed
distally in the guidewire, so that the surgeon can carefully
control, advance, and direct the medical guidewire. With known
devices, there is considerable difference between the amount of
rotation applied at the proximal region of the guidewire and the
amount of rotation developed at the distal end of the guidewire,
making it very difficult for surgeons to maneuver the distal end of
the guidewire.
[0011] Even where the guidewire exhibits the desired torquability
characteristics, and the tools have been properly threaded to the
operative site and have been properly manipulated to perform their
respective functions at the operative site, there remains the
problem noted above, namely, that the process of dilating the
occlusion and/or inserting the stent may dislodge or free small
particles or objects, also known, among other things, as clots,
fragments, plaque, emboli, thromboemboli, etc. More particularly,
with respect to endovascular therapy, the term "embolic event" has
come to be used to describe complications where thrombus or plaque
is shed inadvertently from a lesion to migrate to smaller vessels
beyond the operative site to create a full or partial occlusion of
the lumen of the vessel or vessels. This is most undesirable and
can lead to many complications. These complications are dependent
upon the site in the body where such emboli become lodged,
downstream of the operative site. They include stroke, myocardial
infarction, kidney failure, limb loss or even death. With
increasing emphasis, surgeons state the need to reduce the
likelihood of complications such that assurance against embolic
events will become the typical result of endovascular therapy.
[0012] During the previously described procedures, it is necessary
to remove tools, devices and catheters from a patient via a
guidewire while the guidewire itself remains in the patient.
Typically during a procedure, a torquer is placed on and removed
from a guidewire each time a new device is utilized. This
necessitates the complete removal of the torquer from the guidewire
by sliding the torquer to the proximal end of the guidewire. The
guidewire being of considerable length, relates to several awkward
motions which again can cause damage to the intima of the vessel.
The torquer is also advanced several times along the guidewire with
the use of each new tool. With most torquers, this requires a
two-handed action to loosen, slide and then retighten the torquer
before the next step in the procedure can be made, this is time
consuming and costly to both the physician and patient.
[0013] Devices are seen in the art that assist in the manipulation
of the guidewire external to the surgical opening, such that the
internally displaced distal end of the guidewire may be maneuvered
through the vessel as a result of movement from the guidewire's
proximal end.
[0014] U.S. Pat. No. 6,030,349 to Wilson et al. teaches a medical
guidewire torquer comprising a single cylindrical body having a
groove displaced therein for receiving the wire, wherein an amount
of pressure may be applied to the medical guidewire so movement and
immobilization of the torquer along the proximal end may be
performed.
[0015] U.S. Pat. No. 5,325,868 to Kimmelstiel shows a self-gripping
medical wire torquer which includes a single sleeve body having a
clamping device and a release mechanism for temporarily releasing
the clamp means to slide and reposition the torquer along the
wire.
[0016] Other devices for manipulating a medical guidewire are known
in the art, but these and the above devices suffer generally, not
only because of the above reasons for lack of torquability, but
because of cost considerations and their inherent complexity.
Because of concerns for sterility, and the need for ease of use, a
surgeon will typically dispose of torquer devices regularly during
different stages of the advancement of the guidewire, even for the
same patient. Surgeons have found that it is more expedient to have
many disposable torquer devices available than to repeatedly
reposition and keep track of a single torquer. For this reason,
simplicity of design and the ease of use by one-hand manipulation
is of utmost importance.
[0017] There is need then in the art for a torquer device to
maximize torquability, which is simple in design, easy to mount on,
slide upon, and remove from the medical guidewire, using a
single-hand clamping technique.
SUMMARY OF THE INVENTION
[0018] It is an objective of the present invention to provide a
torquer for a medical guidewire that may be mounted, repositioned,
and removed using a single-hand release and fastening means.
[0019] It is further an objective of the present invention to
provide a torquer having a means to facilitate the manipulation and
maneuverability of the guidewire.
[0020] It is further an objective of the present invention to
provide a torquer having a grip surface positioned on the top
and/or bottom surface thereof to further assist in the manipulation
and maneuverability of the guidewire.
[0021] It is further an objective of the present invention to
provide a torquer having an efficient means for removably
positioning the torquer along the length of the guidewire.
[0022] It is further an objective of the present invention to
provide a torquer of one-piece design, thereby facilitating the
manufacture and disposability thereof.
[0023] Accordingly, the above and other objectives are met by
providing a torquer for maneuvering a guidewire, comprising a top
arm having a top distal end and a top proximal end; a clamping
tongue disposed downwardly from the top distal end; a bottom arm
having a bottom distal end and a bottom proximal end, the bottom
proximal end flexibly connected to the top proximal end by means of
a flap hinge; a proximal slit defined horizontally between the
bottom proximal end and the top proximal end; and a distal slit
defined vertically within the clamping tongue, wherein each slit is
adapted to receive the medical guidewire, thereby enabling the
guidewire to be maneuvered by the torquer when the torquer is
clamped shut.
[0024] The present invention then will open and close in a clamping
manner. In its closed position the clamping tongue will be clipped
onto a bottom lip abutting the bottom distal end of the bottom arm
as the wire is positioned within each slit. The wire may further be
situated within a wire channel means defined on the surfaces of the
bottom and top arm when the arms are closed, thereby keeping the
torquer in a removably fixed position and the particular portion of
the guidewire enveloped by the torquer in a stable position. This
will result in the ability of the user to manipulate and/or
maneuver the guidewire from the point at which the torquer is
attached.
[0025] In its open position, the torquer may simply be pulled away
from the guidewire (as opposed to being slid off the end of the
guidewire, thus allowing for a rapid exchange of tools and/or
devices), or the guidewire can remain within the proximal slit
and/or the distal slit, thus allowing the torquer to slide and
travel along the length of the guidewire and simply be repositioned
along the guidewire at an alternative point by clamping and
snapping the two arms together.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] FIG. 1 is a perspective view of the torquer in an open
position.
[0027] FIG. 1a is a rotated perspective view of the torquer in in
an open position.
[0028] FIG. 2 is a perspective view of the torquer in an open
position showing the location of the medical guidewire.
[0029] FIG. 3 is a perspective view of the torquer in a closed
position showing the medical guidewire positioned therein.
[0030] FIG. 4 is a side view of the torquer in a closed position
with the guidewire positioned therein.
[0031] FIG. 5 is a side view of the torquer in an open position
showing the guidewire positioned within the flap hinge.
[0032] FIG. 6 is a top view of the torquer with the guidewire
positioned therein.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0033] The invention will now be described in detail in relation to
a preferred embodiment and implementation thereof which is
exemplary in nature and descriptively specific as disclosed. As is
customary, it will be understood that no limitation of the scope of
the invention is thereby intended. The invention encompasses such
alterations and further modifications in the illustrated method,
and such further applications of the principles of the invention
illustrated herein, as would normally occur to persons skilled in
the art to which the invention relates.
[0034] FIGS. 1-6 demonstrate the present invention in the form of a
torquer 1 configured to be positioned on a guidewire 2. In the
preferred embodiment, the guidewire 2 suited for use with the
present invention is a medical guidewire 2, wherein the torquer 1
is positioned on or fastened to the portion of the medical
guidewire 2 external to the patient, such that the medical
guidewire 2 is then capable of being manipulated or maneuvered
through a blood vessel or other tract by a surgeon. The guidewire 2
is typically in the range of 0.011 inches-0.040 inches in diameter,
typically 0.014 inches in diameter. As should be understood, the
dimensions of any wire-receiving portions manufactured for the
torquer 1 may vary according to the dimensional specifications of
the guidewire 2.
[0035] The torquer is generally comprised of a top arm 14 and a
bottom arm 15. The top arm 14 is hingedly attached to the bottom
arm 15 in a way that enables the two arms to function in a clamping
manner. Though any type of hinge may be used, in the preferred
embodiment, the torquer 1 is a one-piece mold design of rubber or
plastic or the like wherein the top arm 14 is attached to the
bottom arm by means of an integral, flexible flap hinge 17.
Specifically, the top arm 14 has a top distal end 22 and a top
proximal end 10 relative to the flap hinge 17 of the two arms. The
bottom arm 15 has a bottom distal end 38 and a bottom proximal end
48. Thus, the bottom proximal end 48 is flexibly connected to the
top proximal end 10 to form the flap hinge 17.
[0036] A clamping tongue 24 is attached or integrally formed and
downwardly disposed from the top distal end 22. Defined within the
clamping tongue 24 is a generally vertical distal slit 26. In the
preferred embodiment, the distal slit 26 is defined medially within
the clamping tongue 24. The distal slit 26 is appropriately
sized/defined with a width which allows the guidewire 2 to fit
therein.
[0037] As a preferred means for clamping the top arm 14 to the
bottom arm 15, a tongue clip 28 is provided on the tip 25 of the
clamping tongue 24. The tongue clip 28 is formed on the tip 25 and
projects slightly upward and inward therefrom. The tongue clip 28
is configured to snap onto a bottom lip 36 integrally formed on the
bottom distal end 38 of the bottom arm 15. The bottom lip 36 may be
any type of abutment formed of a suitable shape to allow the
clamping tongue 24 to fasten to the bottom arm 15. Thus, the top
arm 14 with the distal slit 26 is configured to clamp and snap down
onto the bottom arm 15. To open the torquer 1, the clamping tongue
24 is simply pushed away from the bottom lip 36 to disengage the
tongue clip 28 from the bottom lip 36.
[0038] Furthermore, a proximal slit 50 is horizontally defined
within the flap hinge 17. Similar to the vertical distal slit 26,
the proximal slit 50 is sized/defined to allow the guidewire 2 to
fit therein. Preferably, the horizontal length of the proximal slit
50 is one-half the width of the flap hinge 17 so that the guidewire
2 can be positioned medially within the torquer 1. Thus, in
operation, the torquer 1 is fastened to the guidewire 2 by aligning
and sliding the proximal slit 50 onto the guidewire 2 with the
torquer 1 in an open position (see FIG. 5). The guidewire 2 is then
snapped into the two groups of projections 34 (as further
described) which entrap the guidewire 2 and allow for easy sliding
of the torquer 1. The top arm 14 and bottom arm 15 are then clamped
together as the guidewire 2 slides into the distal slit 26 of the
clamping tongue 24.
[0039] As a preferred embodiment as a means for further securing
the torquer 1 on the guidewire 2 and to provide greater
torqueability to manipulate the guidewire 2, a wire channel means
is provided on at least one of the surfaces with which the
guidewire 2 will come into contact when the torquer is clamped shut
on the guidewire 2. The bottom arm 15 has a top surface 40. The top
arm 14 has an underlying surface 18 aligned with and which opposes
the top surface 40 of the bottom arm 15. The wire channel means is
formed on either or both of the top surface 40 and underlying
surface 18. As shown, multiple and alternating projections 34 are
integrally formed on the top surface 40 of the bottom arm 15
positioned near the bottom distal end 38 and in a spaced apart
relation to provide a channel in which the guidewire 2 may be
positioned. A longitudinal groove 34a or detent is formed on each
projection 34 of the bottom arm 15. Each groove 34a further nests
the guidewire 2 while allowing the guidewire 2 to rotate freely and
move longitudinally within the torquer 1. In an unlocked position,
the torquer 1 can advance rapidly along the wire and easily be
positioned. The grooves 34a also prevent the torquer 1 from falling
off the guidewire in an unlocked position. The guidewire 2 fits
into each groove 34a, and a second compression or "snap" of the
torquer 1 closes the two arms and "locks" the torquer 1 into a
position on the guidewire 2 so that the torquer 1 can rotate and
advance the guidewire 2.
[0040] Preferably, another group of projections 34 are then
situated near the bottom proximal end 48, and also on similar
opposing positions on the underlying surface 18 of the top arm 14.
The projections 34 on the underlying surface 18 are positioned in
an alternating manner which allows them to mate with the underlying
projections 34 on the top surface 40 of the bottom arm 15, thereby
firmly "locking" the guidewire 2 in place. In a similar fashion,
and as should be equivalently understood, the wire channel means
may be constructed using these projections 34, but which
projections 34 travel the length of the top surface 40 and/or the
underlying surface 18. The wire channel means may further be simply
a single channel defined on either the underlying surface 18 or top
surface 40 by parallel rail members (not shown) adapted to receive
the guidewire 2 and having a width similar to the distal slit 26
and/or the proximal slit 50. The underlying surface 18 may further
be either flat or ribbed with one or more teeth to allow the arms
to mate to one another while securing the guidewire 2.
[0041] As a further embodiment, a portion of the top arm 14 and/or
the bottom arm 15 may be enlarged to enhance the torqueability of
the torquer. As shown, leverage is enhanced by providing a torque
assist area 42, which is generally a partially or entirely expanded
portion of the top arm 14 and/or the bottom arm 15. A grip of the
user may further be enhanced by providing a more frictional or
rubber-like grip surface 20 on or near the top distal end 22 and/or
the bottom distal end 38.
[0042] Thus, the present invention is constructed to give high
torqueability between the rotation applied proximally at the
proximal region of the guidewire and the rotation developed
distally in the guidewire, so that the surgeon can carefully
control and direct the medical guidewire 2 and easily position and
re-position the torquer 1 along the length of the medical guidewire
2.
* * * * *